This study is done on Qaem hospital ; within two years
This stydy is double blinded , patients and evaluators are blinded.
Participants/Inclusion and exclusion criteria
Patient without systemic disease ; without any surgery in face ; minimum age 18 and maximum age 35
previous nose surgery ; heart failure ; abnormal bleeding.
Intervention groups
Internal and external lateral osteotomy
Main outcome variables
Decrease edema , ecchymosis, step and pain after surgery
General information
Reason for update
Acronym
CEILNOPRC
IRCT registration information
IRCT registration number:IRCT20191221045835N1
Registration date:2020-02-01, 1398/11/12
Registration timing:retrospective
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
sara samiee rudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 8092
Email address
samiees931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-02, 1396/02/12
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
2017-05-02, 1396/02/12
Actual recruitment end date
2017-08-06, 1396/05/15
Trial completion date
2018-12-16, 1397/09/25
Scientific title
Comparison of external and internal lateral nasal osteotomy on primary rhinoplasty complications
Public title
Comparison of external and internal lateral nasal osteotomy on primary rhinoplasty complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ages between 18 -35
without any previous operation on face erea
without systemic disease
simple
For randomization, sheets with title A and B are placed inside the box.A represent external osteotomy and B represent internal osteotomy. Patients randomly selected these sheets.The patients were visited by surgeon according to the selected tab.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient were blind . they choose a packet which has the surgery method.
Assessors were blind ; by the codes were given to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakil abad Blvd , Mashhad dental university
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2019-07-24, 1398/05/02
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.023
Health conditions studied
1
Description of health condition studied
The comparison of edema , ecchymosis , step and pain between two groups of lateral internal and external osteotomy .
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of edema , ecchymosis , step and pain
Timepoint
2 , 7 and 21 days after surgery
Method of measurement
Evaluation of edema and ecchymosis with Kara and Gokalan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Internal lateral osteotomy Surgical procedure under general anesthesia with Fentanyl , Halothane and Nesdonal.10 minutes before lateral osteotomy , Adrenalin(1/100/000) with Lidocaine (%1) injected into the desired area. All surgeries are done by a surgeon in Qaem hospital education center with a protocol of anesthesia.edema ,check out ecchymosis and step off deformity after 2,7 and 21days after surgery by a person(non-surgical surgeon).And observations were based on comparison with available forms in questionnaire rating.
Category
Treatment - Surgery
2
Description
Control group: External lateral osteotomy Surgical procedure under general anesthesia with Fentanyl , Halothane and Nesdonal.10 minutes before lateral osteotomy , Adrenalin(1/100/000) with Lidocaine (%1) injected into the desired area.All surgeries are done by a surgeon in Qaem hospital education center with a protocol of anesthesia.edema ,check out ecchymosis and step off deformity after 2,7 and 21days after surgery by a person(non-surgical surgeon).And observations were based on comparison with available forms in questionnaire rating.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Dr.Mahdi gholami
Street address
Ahmad abad Ave , Qaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
gholamiMH@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Street address
Vakil abad Blvd , Dental university
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7278
Email
Bagherih@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil Abad Ave , Dental University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
GholamiM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil Abad Ave , Dental university
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
GholamiM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil Abad Ave , Dental university
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
GholamiM@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available